The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Infant Warmer.
| Device ID | K833802 |
| 510k Number | K833802 |
| Device Name: | INFANT WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | KINETIC CONCEPTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-01 |
| Decision Date | 1984-04-05 |